Program to Avoid Cerebrovascular Events through Systematic Electronic Tracking and Tailoring of an Eminent Risk factor: Protocol of a RCT.

ABSTRACT

BACKGROUND: Geographical and racial disparities in stroke outcomes are especially prominent in the Southeastern United States, which represents a region more heavily burdened with stroke compared to the rest of the country. While stroke is eminently preventable, particularly via blood pressure control, fewer than one third of patients with a stroke have their blood pressure controlled ≥ 75% of the time, and low consistency of blood pressure control is linked to higher stroke risk. OBJECTIVE: To demonstrate that a mHealth technology-centered, integrated approach can effectively improve sustained blood pressure control among stroke patients (half of whom will be Black). DESIGN: The Program to Avoid Cerebrovascular Events through Systematic Electronic Tracking and Tailoring of an Eminent Risk-factor is a prospective randomized controlled trial, which will include a cohort of 200 patients with a stroke, encountered at two major safety net health care systems in South Carolina. The intervention comprises utilization of a Vaica electronic pill tray & blue-toothed UA-767Plus BT blood pressure device and a dedicated app installed on patients' smart phones for automatic relay of data to a central server. Providers will follow care protocols based on expert consensus practice guidelines to address optimal blood pressure management. STUDY OUTCOMES: Primary outcome is systolic blood pressure at 12-months, which is the major modifiable step to stroke event rate reduction. Secondary endpoints include control of other stroke risk factors, medication adherence, functional status, and quality of life. DISCUSSION: We anticipate that a successful intervention will serve as a scalable model of effective chronic blood pressure management after stroke, to bridge racial and geographic disparities in stroke outcomes in the United States. TRIAL REGISTRATION ClinicalTrials.gov - NCT03401489.